Epistaxis (nosebleed) is very common. Although in most cases the symptoms are temporary and non-recurrent, some patients experience recurring and severe symptoms. The most common method of treating severe epistaxis is by cauterization of the bleeding vessel. When the source of bleeding cannot be seen, intranasal packing using cotton tampons or inflatable rubber balloons may be employed, but such methods cause inconvenience and discomfort for the patient. The cotton tampons typically have a width of 2 cm and a length of 40-100 cm. They are pressed into the nose to stop bleeding by applying pressure to the nasal mucosa and may stay in place for 1-4 days. Inflatable rubber balloons also act by applying pressure to the nasal mucosa, and may remain in place for 1-2 days. Whether tampons or balloons are employed, either is painful when inserted, interferes with normal breathing and may lead to local infection. There is a need for treatments which do not have such disadvantages.
WO 01/00218 describes a nasal spray formulation which includes Dead Sea salt in a concentration of about 0.5 to 5 g/l of sterile aqueous solution, contains a buffer and is essentially free of noxious, organic impurities. The formulation is said to be for use in treating rhinitis, sinusitis, epistaxis and post-surgical irritation, but no trials relating to epistaxis are reported.
Different nasal gel applications and vasoconstrictors have been studied experimentally, see Bende et al, Acta Otolaryngol (Stockh) 88, 459-461 (1979); Bende et al, Acta Otolaryngol (Stockh) 102, 488-493 (1986); and Bende et al, Acta Otolaryngol (Stockh) 110, 124-127 (1990). Earlier clinical investigations indicated that fibrinolysis plays a role in recurrent epistaxis, see Petruson et al, Acta Otolaryngol (Stockh) suppl. 317 (1974). Tibbelin et al, ORL (Basel) 57, 207-209 (1995) explored the haemostatic effect of local application of a tranexamic acid gel and a placebo gel in a randomized, double-blind, multicentre clinical trial. Both gels were found to have a beneficial effect, and surprisingly the placebo gel was found to be slightly (though not significantly) better than that containing the tranexamic acid (an inhibitor of the fibrinolytic system).